Positive results from second pivotal phase III trial for Lodotra

Sep 2 2009

CAPRA-2-Data Will be Used to File for US Marketing Approval

Nitec Pharma AG ("Nitec" or "Nitec Pharma"), a Switzerland-based specialty pharma company focused on the development and commercialization of medicines to treat chronic inflammation and pain-related diseases, today announced positive results from the second pivotal phase III trial for its lead product, Lodotra(TM).

The CAPRA-2 study (Circadian Administration of Prednisone in Rheumatoid Arthritis-2) was a 12-week, multicentre, double-blind phase III trial evaluating the safety and efficacy of Lodotra(TM) for the treatment of rheumatoid arthritis ("RA"), a chronic, progressive and disabling autoimmune disorder. In total 350 patients, all inadequate responders to DMARD therapy, were randomised in one of two arms to receive either Lodotra(TM) (5mg once daily), or placebo in addition to their existing therapy. The primary efficacy endpoint was the ACR-20 response rate, which is defined as at least a 20% improvement in a number of disease-specific criteria. The key secondary endpoint was the change in the duration of morning stiffness of the joints. CAPRA-2-data will be used to file for US marketing approval with the FDA together with the data already available from the CAPRA-1 pivotal phase III trial which has shown the superiority of Lodotra(TM) over standard prednisone treatment.

Lodotra(TM)-treated patients showed an ACR-20 response of 49% compared to 29% in the placebo group. The difference was highly significant>

Dr. Anders Harfstrand, CEO of Nitec commented: "We are delighted to report successful and very positive outcomes of the CAPRA-2 study. These strongly underline the benefits of Lodotra(TM) in the treatment of RA. The study confirms clearly that the innovative delivery system of Lodotra(TM) is able to adapt the timing of glucocorticoid treatment to a patient's circadian rhythm in order to improve the efficacy and safety of prednisone. CAPRA-2 is the first pivotal phase III study to demonstrate the ACR-20 response of a very low dose of prednisone as a primary endpoint. Following the successful European launches of Lodotra(TM) and the positive feedback that we have received from RA specialists, we look forward to completing the regulatory process in the US."

LodotraTM, Nitec's novel single-pulse delayed-release ("SPDR") low-dose prednisone tablet, was launched in Germany by Merck KGaA, which holds the exclusive distribution rights for Germany and Austria. In April 2009 Mundipharma acquired the distribution rights to LodotraTM in the rest of Europe and Nitec retains all commercialization rights for the US and rest of the world.